Clonal Evolution in Follicular Lymphoma

NCT03190928 | Recruiting

• 2 other identifiers: 17010517-C-0105
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Follicular lymphoma is a type of cancer of the lymph nodes. Lab studies are important for cancer research. They help scientists better understand differences in the cancer biology of different patients. Researchers want to collect serial samples over time from people with follicular lymphoma to help them design future treatments. Objective: To collect a variety of samples from people with follicular lymphoma to study how these diseases progress and respond to treatment. Eligibility: Adults at least 18 years old who have been diagnosed with, but have not yet had any treatment for, follicular lymphoma. Design: Participants will be screened with medical history and physical exam. They will answer questions about daily functioning. They will have blood and urine tests. They may have scans and have tissue samples taken. Participants will be monitored about every 4 months for up to 2 years. They will repeat screening tests. They will have a cheek swab. A small brush will be rubbed against the inside of the cheek to wipe off some cells. Participants will have imaging scans about every 8 months for up to 2 years. Participants may have a bone marrow aspiration and biopsy. The hipbone will be numbed with a small needle. A needle will be put into the hipbone, and about 2 tablespoons of bone marrow will be taken out through the needle. Participants will continue being monitored every 6 months for up to 5 years, then 1 time a year.

Conditions

Follicular Lymphoma

Keywords

Disease Monitoring; Molecular Monitoring; Novel Biomarker Identification; Gene Expression Analyses; Watchful-Waiting; Natural History

Outcome Measures

Primary Outcomes (2)

• Characteristics of treatment received (e.g., type, response, etc.) and molecular biology (e.g., pathology, histologic transformation) will be described

  The types and frequency of each treatment will be reported.

  ongoing

• Time to initiation of first-line systemic treatment (TTT1), defined as the number of days from study enrollment until the date of initiation of first-line systemic treatment

  Number of days from study enrollment until the date of initiation of first-line systemic treatment will be reported.

  2 years

Secondary Outcomes (5)

• Progression-free survival

  2 years

• Progression-free survival after first-line systemic treatment, defined as the number of days from diagnosis to objective disease progression after first-line systemic treatment

  5 years

• Progression-free survival from first active lymphoma treatment

  5 years

• Time to initiation of second-line systemic treatment

  5 years

• Overall survival (OS)

  10 years

Study Arms (1)

1

Patients with grades 1-2 or 3a follicular lymphoma (FL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Up to 200 patients with pathologically-confirmed follicular lymphoma (grades 1-2, 3a) will be enrolled and screened for eligibility, and up to 80 eligible patients will receive active surveillance on this study for the purpose of expert monitoring of their disease, improved risk-stratification, and donation of tissue and cellular products for research.

You may qualify if:

• Histologically or cytologically confirmed follicular lymphoma (FL), grades 1-2, or 3a confirmed by the Laboratory of Pathology, NCI; patients who meet criteria for immediate initiation of systemic therapy are eligible
• Adequate tissue available from original diagnostic biopsy.
• NOTE: If biopsy was \>12 months prior to enrollment OR adequate tissue is not available, tissue biopsy may be optionally repeated unless such a biopsy is considered unacceptable risk to the patient. Patients without adequate tissue are eligible at the discretion of the PI.
• \- Must have disease that is measurable or evaluable on either computed tomography (CT) scans or FDG-positron emission tomography (FDG-PET) scans
• NOTE: Since patients with FL may have lesions that wax and wane on imaging, the requirement for disease being measurable or evaluable can come from imaging taken at any time at or after diagnosis, the most recent imaging prior to enrollment does not need
• to show measurable or evaluable disease.
• \- Age greater than or equal to 18 years
• NOTE: Patients with the pediatric-type follicular lymphoma are usually \<18 years of age, and often have a very different clinical course than patients with the adult-type of FL. Due to this difference in biology, children are excluded from this study.
• \- ECOG performance status \<2 (Karnofsky \>60%)

You may not qualify if:

• Previous history of diffuse large B-cell lymphoma or histologic transformation
• Any prior systemic treatment for lymphoma including cytotoxic chemotherapy, biologic therapy, and monoclonal antibody therapy (radiotherapy permitted); patients who have received chemotherapy, biologic therapy, hormonal therapy, or monoclonal antibody for other malignancies are potentially eligible provided that all of the following are true: a) that malignancy was not lymphoma, b) systemic therapy ended at least 3 years prior to the diagnosis of FL, and c) there is no evidence of active malignancy other than FL
• NOTE: Initiation of first-line systemic therapy is allowed while on this trial; concurrent participation in first-line treatment clinical trials will be permitted.
• Patients who are HIV-positive
• Any second malignancy that requires active systemic therapy
• Any other (non-lymphoma) life-threatening disease
• Patients unable to provide informed consent (surrogates will not be used)
• Pregnant women are excluded from enrollment onto this study because the invasive procedures and/or sedation needed to perform them may cause unnecessary harm to the unborn fetus. In the event a woman becomes pregnant while on study, she will not be removed from the study; however, no follow-up invasive clinical or research procedures will be done that include unacceptable to risk to the patient and/or to the unborn fetus.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rahul Lakhotia, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NCI Medical Oncology Referral Office

CONTACT

(240) 760-6050; ncimo_referrals@nih.gov

Rahul Lakhotia, M.D.

CONTACT

(240) 858-7242; rahul.lakhotia@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 19, 2017
• Study Start: July 27, 2017
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-02-23

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)